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BRight DCB First-in-Human Study

NCT04525794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-22

No results posted yet for this study

Summary

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).

The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.

Conditions

Interventions

DEVICE

BRight DCB

The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.

Sponsors & Collaborators

  • Biotronik AG

    collaborator INDUSTRY

  • Biotronik CRC Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2023-09-20
Completion
2024-02-02

Countries

  • Australia
  • Austria
  • Germany
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04525794 on ClinicalTrials.gov